Earlier this month, five Insys Therapeutics pharmaceutical executives were found guilty of racketeering for their attempts to bribe doctors to prescribe the company's Subsys fentanyl spray, which was approved as a pain reliever for cancer patients, to people who didn't even need it. Their scheme included strippers, guns, cash, and even a rap video including a dancing drug bottle mascot. It's also linked to more than 900 overdose deaths.
Publication Date: 5/20/19
Runtime: 13 mins, 21 seconds
Article Referenced: "Top Executives of Insys, an Opioid Company, Are Found Guilty of Racketeering," New York Times, 5/2/19
Kellie: This week in the news was a report that shocked me: “Lap dance given as bribe in big pharma scheme.” Physicians accepting bribes, boosting sales of a fentanyl spray. And to make matters worse, there was even a rap video made. [rap music] If it was this hard for me to see these things and come to terms with, what must it be like for our patients to hear and see these stories? How terrifying for them!
Welcome to Episode 2 of The Carlat Psychiatry Podcast, brought to you by The Carlat Report, a CME publication keeping psychiatry honest since 2003. I’m Kellie Newsome, a psychiatric NP student and a dedicated reader of every issue.
Dr. Aiken: And I’m Chris Aiken, the Editor-In-Chief of The Carlat Psychiatry Report.
Kellie: When the FDA approved a fentanyl spray for cancer-related pain in 2012, they had no idea how badly things would get out of hand. This is the story of strippers, guns and cash - lengths that the pharmaceutical industry went to promote this opioid that took the lives of over 900 patients.
The company was Insys Therapeutics. The drug was Subsys and the chairman was John Kapoor. Last week he was found guilty of bribing physicians to prescribe high doses of Subsys, fentanyl spray that is a hundred times stronger than morphine. The allegations are astonishing. Subsys was approved for pain associated with terminal cancer, but the company convinced doctors to fabricate this diagnosis in order to prescribe it to patients who didn’t even need it. Those patients quickly became addicted to the synthetic opioid, resulting in high doses, more profits for the company, and over 900 overdose deaths.
Doctors were paid kickbacks of up to $800,000 to prescribe the drug. And to hide the kickbacks, the company created fake speakers programs, where the physicians spoke to their friends and fellow employees for large sums of money. According to CBS news, Insys made 18,000 payments to doctors in 2016 alone.
They selected attractive women to work as drug reps and instructed these women to stroke the hand of the physician while pleading with him to prescribe high doses to his patients. Reportedly, these women were treated poorly in the misogynistic culture the company created. And the regional sales manager, Sunrise Lee, was a former stripper who gave the physicians lap dances while touting the merits of the drug. Prior to taking on the role of regional sales manager, Sunrise’s management experience involved running an escort service, prosecutors said.
Other antics included taking physicians on expenses-paid outings to shooting ranges and promoting the drug with a hip-hop video that instructed doctors on how to raise the dose higher and higher.
The money to fund this scheme was not hard to come by. A single patient who was started on Subsys could generate over $100,000 in revenue for the company.
Dr. Aiken: Wow. I just don’t know where to start with this.
Kellie: You know, all this talk of guns and strippers is really a distraction. This story is about over 900 patients who died from taking a drug that they didn’t even really need to be on. And every other patient that comes and sees us tomorrow that sits in our office who reads this story and wonders if we’ve been given any kind of kickbacks or have any influence over the kind of care that they’re receiving.
Dr. Aiken: Well, that really brings it home. And you’re right, Kellie. A lot of times patients will ask me if I got a kickback for prescribing a drug that I’ve chosen for them and I gotta say, it’s not an unreasonable question. Although this story is about pain doctors and a pain prescription, similar kinds of things have happened in the psychiatric world.
Kellie: Like what?
Dr. Aiken: Well, a prominent case was in 2013. Johnson & Johnson who make Risperdal, they were successfully sued by the federal government for improperly promoting the drug to older adults, children, and people with disabilities. Now, in that case, they gave kickbacks to doctors that were also disguised as speakers’ fees. What they would do is get the doctor on the speakers panel – usually the doctor had no speaking ability or academic background – and then tie the number of talks the doctor was able to give or the price for those talks to the number of prescriptions the doctor was writing.
Kellie: You said they promoted Risperdal in children and the elderly. What’s wrong with using it in these populations?
Dr. Aiken: Well, in the elderly there’s risk of stroke and increased death and it might seem like it’s an innocent thing that the drug company didn’t know that at the time. This was back in the late 90’s and early 2000’s, but they did. And they did and they found internal documents that the company was aware of this problem and covering it up.
In children, there’s breast growth. Young boys were getting breast enlargement from taking Risperdal and what they were doing, they established a branch of their sales force called “ElderCare”, which was meant to promote Risperdal to the elderly. And it’s really a very simple thing, you see, the behavioral symptoms of dementia – that’s agitation, paranoia. These resemble schizophrenia, so it wasn’t hard for the company to make the implication that since Risperdal treats schizophrenia, it’s also going to treat this.
We now know this is a big problem. We’re still living with the ramifications of that problem. We’re still trying to get a lot of the elderly nursing homes off antipsychotics. In fact, we covered that a couple of months ago in The Carlat Report and how to de-prescribe medications.
Kellie: So, they had doctors promoting the drug and getting kickbacks. What else did they do?
Dr. Aiken: Well, Johnson & Johnson did go further. They teamed up with the largest pharmacy chain at the time. It went by the Orwellian name of Omnicare, and they gave kickbacks to Omnicare as well. Now, how did they do this? How did they get pharmacists to promote the drug? What they did, they hired pharmacists to go into nursing homes once a month, read the doctors’ charts and make clinical recommendations about what to do.
Now, this is a world where agitation in the elderly and in people with dementia, really nobody knows what to do. So, this is a very vulnerable population – they don’t have a voice, and the doctors and nurses are at a loss. So, I imagine people were pretty receptive to the pharmacists’ idea which was, generally, to prescribe Risperdal and the pharmacist would get a kickback. Those kickbacks were also hidden in the form of educational grants and rebate payments. But to the pharmacists’ credit, it was actually some of them who were the whistle-blowers and spoke up about this, not the doctors.
Kellie: I can see how people buy into that, because the symptoms of agitation in dementia resemble symptoms of agitation in schizophrenia.
Dr. Aiken: You’re right. And I think one way to limit the influence of the pharmaceutical industry is to prescribe medications based on diagnoses, like we’re supposed to do, not on symptoms. The industry’s main goal is to expand the use of their product and create a bigger and bigger market. And it’s easy to do that with symptoms because everybody has symptoms of agitation and anxiety. Everybody gets a little depressed.
One time, a rep for Saphris/asenapine, came up to me and showed me a study in schizophrenia and the only thing she highlighted was that it led to improvements on the anxiety rating scale. Now, sure, if you treat people who are paranoid and have active psychosis, I’ll bet their anxiety is going to go down. But the implication was that I should use this drug for anyone with anxiety.
Another common tactic is to try to influence us through talk about the mechanism of action. Now to me, the mechanism of action very rarely really relates to what the drug does. There are medications that treat depression by enhancing serotonin, and there are medications like mirtazapine that treat depression and are serotonin blockers. So, none of this is very intuitive. Through that kind of mechanistic thinking, the Johnson & Johnson company was also promoting Risperdal for ADHD and we’ll get into this in a later podcast. We’re going talk all about the antipsychotics and how they are promoted for cognition and ADHD and what the myths and realities are around that.
Kellie: So, Risperdal seems to be the one getting a bad rap. Are there any others that went down the same path?
Dr. Aiken: Yes, there are. We know it happened at least with Zyprexa,/olanzapine, Seroquel/quetiapine, which are both antipsychotics and Depakote, a mood stabilizer that’s often used for agitation. All of these drugs have similar problems in their marketing and they all settled with the federal government for similar kinds of marketing infractions.
And then, there Trileptal, and we’ll end with that story. In 2010, Novartis, the maker of Trileptal, paid $237 million to resolve a civil lawsuit over kickbacks with this drug. And here it was the same kind of story. They were giving doctors kickbacks to give talks and prescribe more of the Trileptal. There’s a direct relationship between how much they prescribed and how much money they were given. And they were using it off-label. And one of those off-label uses was bipolar disorder.
Now, this is where I get a little upset about the whole thing, because there were a lot of talks about 10 or 15 years ago with the innuendo that Trileptal could help bipolar disorder. Then it was found to be illegal and wrong. The company paid the money. But they simply pulled the plugs on the talks. What they really need to do is make these companies give talks retracting that information.
No one is giving on how Trileptal really doesn’t treat bipolar disorder. No one is writing papers or giving presentations on the unpublished data where it failed to treat mania. And to this day, many practitioners are still using oxcarbazepine/Trileptal in place of the FDA-approved carbamazepine out of the mistaken belief that Trileptal is just as effective and a lot better tolerated.
But I’m getting ahead of myself here, as we’re going to cover this Trileptal/carbamazepine controversy in a future issue.
Kellie: It sounds like the industry had a very clear strategy to influence doctors when it comes to paying more when they prescribe more. But were the doctors actually aware of what was going on? What was it like to be one of those doctors?
Dr. Aiken: Yeah, I’ve always wondered about that, and I don’t know myself. I’ve never given promotional talks for drugs. I think it’s something we should ask Danny about.
Kellie: As in Danny Carlat?
Dr. Aiken: Yep. Danny actually did about a year or two as a speaker for Effexor before he started The Carlat Report. In fact, that’s part of the reason he started it. The whole experience changed him in a lot of ways, but one thing was that he realized there were no avenues for physician education that didn’t have some or a lot of influence from the pharmaceutical industry and as a speaker, he was being made to say things that weren’t exactly true.
So, he got out of that business pretty quickly and started this business, The Carlat Report, which I’m glad he did.
Kellie: So, let’s have him on in a future episode, because we’re out of time right now.
Dr. Aiken: And I hope you’ll join us next Monday where we are going to talk about antipsychotics and cognition and unravel a few of the pharmaceutical myths around that one.
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